- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325409
Sports Nutrition Benefits of Weizmannia Coagulans BC99
December 24, 2025 updated by: Wecare Probiotics Co., Ltd.
Sports Nutrition Benefits of Weizmannia Coagulans BC99: a Randomized Controlled Trial on Muscle Function and Recovery in Healthy Participants
To evaluate the clinical efficacy of Weizmannia coagulans BC99 in young Chinese patients with exercise-induced muscle damage compared with placebo, and to explore its effects on inflammatory responses and intestinal microbiota.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Henan
-
Luoyang, Henan, China, 471000
- Wu Ying
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy adults aged 19-35 years, with no restriction on sex;
- Physically active individuals with regular daily exercise training intensity and duration;
- No history of allergy to protein products;
- Body weight ≥50 kg for male subjects and ≥45 kg for female subjects; body mass index (BMI), calculated as weight (kg) divided by height squared (m²), within the range of 19.0-24.0 kg/m²;
- No history of cardiovascular or cerebrovascular diseases, hypertension, diabetes, hepatic or renal dysfunction, or other underlying diseases or metabolic disorders;
- Willingness to comply with the study protocol and study restrictions, and voluntary provision of written informed consent to participate in the study.
Exclusion Criteria:
- History of allergic constitution or immunodeficiency;
- Blood donation or significant blood loss (≥200 mL) within 3 months prior to administration of the investigational product;
- Presence of severe diseases of major organs, including the cardiovascular system, lungs, liver, or kidneys, as well as diabetes mellitus, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system diseases;
- Use of medications affecting the intestinal microbiota (including antibiotics, microecological preparations, intestinal mucosal protectants, traditional Chinese medicines, etc.) for more than one consecutive week within 1 month prior to screening;
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo group
3g dose of milk protein concentrate/pack, 8 packs per day
|
The experimental phase of this study lasts 12 weeks and each participant will have 3 visits (week 0, week 6, week 12)
|
|
Experimental: BC99 group
3g dose of milk protein concentrate with 6×109 Colony Forming Unit (CFU) W. coagulans BC99/pack, 8 packs per day
|
The experimental phase of this study lasts 12 weeks and each participant will have 3 visits (week 0, week 6, week 12)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain evaluation
Time Frame: 12 weeks
|
Visual analog scale (VAS) was used for assessing the pain level of muscle, ranging from 0 to 10 point (0 means no pain; 10 represent worst imaginable pain).
VAS scores were recorded at 24h, 48h and 72h after the intense exercise work stress.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cortisol in plasma
Time Frame: 12 weeks
|
This indicator was determined using commercially available assay kits (BYabscience, Nanjing, China).
|
12 weeks
|
|
Peptide YY in plasma
Time Frame: 12 weeks
|
This indicator was determined using commercially available assay kits (BYabscience, Nanjing, China).
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
March 10, 2024
Study Completion (Actual)
March 28, 2024
Study Registration Dates
First Submitted
December 24, 2025
First Submitted That Met QC Criteria
December 24, 2025
First Posted (Actual)
January 8, 2026
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
December 24, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- WK20251225
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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